FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
K Number: K993812
·
Decision Dec 21, 1999
Classifications
1
FEI Numbers
74
Registration Numbers
74
Same Product Code
110
Applicant Total
109
Review Days
41
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Basic Information
- Device Name
- CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K
- K Number
- K993812
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2390
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Hardy Diagnostics
- Date Received
- November 10, 1999
- Decision Date
- December 21, 1999
- Product Code
- JSM
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JSM | Culture Media, Non-Propagating Transport | FDA class 1 | Microbiology |
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